Recalls / —
—#218214
Product
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A
- FDA product code
- FRN — Pump, Infusion
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K251636
- Affected lot / code info
- Lot Code: GTIN 00085412610900, Serial Numbers 3815663, 3823468, 3824743, 3825234, and 3825599
Why it was recalled
Pumps were released without full testing being performed, including occlusion alarm testing.
Root cause (FDA determination)
Employee error
Action the firm took
Firm notified the single customer on 1/13/26 via phone call. Customer was asked to work with on-site service technician to coordinate return of affected product.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Distribution pattern
- States: Ohio Countries: United States
Timeline
- Recall initiated
- 2026-01-13
- Posted by FDA
- 2026-02-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #218214. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.